Northwest Biotherapeutics (OTCQB: NWBO) one of the most exciting stocks trading on the bulletin boards today, is a heavily shorted biotech that recently reported positive top-line results from its phase 3 trial on DCVax®-L for Glioblastoma, the most aggressive type of brain cancer representing a a potential market expected to reach $1.4 billion by 2025. DCVax®-L has succeeded where well over 400 clinical trials for glioblastoma having failed and its highly effective. In the recent Phase 3 clinical trial both median survival and the “long tail” of extended survival were significantly increased in both newly diagnosed and recurrent glioblastoma brain cancer patients treated with DCVax®-L. Investors sentiment is high as countless medical professionals and Doctors have gotten behind DCVax®-L who believe the approval by the MHRA is imminent.
The shorts are trying to mislead investors on too that recently posting a fake MHRA complaint online. According to Fintech there are currently 39 million shares short of NWBO. In December the Company filed a lawsuit in Manhattan alleging Citadel Securities, Susquehanna and “other Wall Street firms drove down the price of NWBO through a series of illicit trading tactics.” It also includes Canaccord Genuity, G1 Execution Services, GTS Securities, Instinet, Lime Trading and Virtu Americas. We will be updating on NWBO when more details emerge so make sure you are subscribed to newsytrends.com by entering your email below.
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The next big step for Northwest bio is the submission of the marketing application to the MRHA in the UK. The MHRA has made DCVax a top priority to review and the review process could move forward very quickly if NWBO utilizes the rolling review submission process. Revenue just in the UK for GBM will be at least $200 million per year.
UK will approve the cancer vaccine DCVax-L this summer from $NWBO. In two UCLA combo trials it currently has 50-65% efficacy against brain cancer. Immunetherapy, non toxic … works against ALL SOLID TUMORS.
As close to a cure we've ever been. pic.twitter.com/o9X7Svpv89
— 🇩🇰 The Danish Dude 🇩🇰 (@FlemmingBruce) April 27, 2023
Northwest bio is a biotechnology company based in Maryland that focused on developing personalized immunotherapy products designed to treat cancers more effectively than current treatments, without toxicities of the kind associated with chemotherapies, and on a cost-effective basis, in both North America and Europe. The Company has a broad platform technology for DCVax® dendritic cell-based vaccines. Over the years NWBO has built up a valuable Intellectual Property portfolio that consisted of 204 issued patents and 59 pending patent applications worldwide, grouped into 11 patent families as of January 1, 2022. Of these, 200 issued patents and 47 pending patent applications directly relate to the Company’s DCVax products
The Company’s lead product DCVax-L is a fully personalized immune therapy made from a patient’s own immune cells (dendritic cells) and antigens (biomarkers) from a sample of the patient’s own tumor. A multi-year set of doses is produced in a single manufacturing batch, which takes 8 days. The product is then stored frozen in individual doses, and is “off the shelf” throughout the treatment regimen. The doses are stored centrally and simply taken out of the freezer and delivered to the physician when needed for the patient’s next treatment.
People wonder why, NW/CEO Powers don’t promote anything until they are ready. They can’t because of stuff like this. But LP is winning this game. $NWBO pic.twitter.com/pkyO82aiVJ
— Fireman02360 (@fireman02360) May 5, 2023
Northwest Bio has built a manufacturing facility in Sawston, UK spanning a total of 88,345 square feet on two floors and initial production capacity comprises two manufacturing suites, occupying approximately 4,400 square feet on the ground floor. These two suites, together with some additional support and storage space, have a potential production capacity of dendritic cell vaccines for about 40 to 45 patients per month, or approximately 450 to 500 patients annually.
Production of the first NW Bio dendritic cell cancer vaccine for a compassionate use patient at the licensed production facility in Sawston started a while ago. Since the issuance of the MHRA licence, Advent Bioservices has been conducting the required post-approval re-validations and testing, and the facility is now ready to scale up the manufacture of cell therapy products for clinical use.
On November 17 NWBO reported that in its Phase III clinical trial both median survival and the “long tail” of extended survival were increased in both newly diagnosed and recurrent glioblastoma brain cancer patients treated with DCVax®-L. The trial has met both the primary and the secondary endpoint under the Statistical Analysis Plan for the trial. The trial results were reported today in a featured publication co-authored by more than 70 physicians from leading institutions across the U.S., Canada, U.K. and Germany, in the peer reviewed cancer journal JAMA Oncology, entitled “Association of Autologous Tumor Lysate-Loaded Dendritic Cell Vaccination with Extension of Survival Among Patients with Newly Diagnosed and Recurrent Glioblastoma”.
The Company believes this is the first time in nearly 20 years that a Phase III trial of a systemic treatment has shown such survival extension in newly diagnosed glioblastoma, and the first time in nearly 30 years that a Phase III trial of any type of treatment has shown such survival extension in recurrent glioblastoma.
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My favorite part of the article: “Looking to the rest of 2023, there are several more specialty drugs anticipated to receive FDA approval. Here is a wrapped-up version of these anticipated approvals.” $nwbo pic.twitter.com/VU2tQXJUoW
— Ida Bogac (@albtur_mnymkrs) May 2, 2023
Glioblastoma is the most common and most lethal form of primary brain cancer. Standard of care (SOC) treatments have been virtually unchanged for nearly 20 years. With SOC treatments, patients typically survive for only about 15-17 months from diagnosis, with the tumor recurring at about 6-8 months from diagnosis and the patients typically surviving for about 7-9 months after recurrence. Five-year survival from diagnosis is only about 5%.
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NWBO has an enormous following of investors, many of them medical professionals who are passionate in their support of DCVax®-L and its ability to completely disrupt the global market for Glioblastoma worth billions starting in the UK where MHRA approval is expected to come in 2023 and then on to the EME, a much larger market, which is believed the best way for eventual approval in the USA. We will be updating on NWBO when more details emerge so make sure you are subscribed to newsytrends.com by entering your email below.
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Disclosure: we hold no position in NWBO either long or short and we have not been compensated for this article.